Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Joseph Werner,MD, Ohio State University
ClinicalTrials.gov Identifier:
NCT01219881
First received: September 27, 2010
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

This is a single-center, prospective, randomized, double-blind, double-arm trial including 68 subjects scheduled to undergo urological cystoscope surgeries under general anesthesia (GA) with intubation through a laryngeal mask airway (LMA) at The Ohio State University Medical Center (OSUMC). Double blinding will be based on both the subject and the research staff being unaware of which trial arm the subject is randomized into. Eligible subjects that provide voluntary and written informed consent will be included in this study.


Condition Intervention Phase
Cystoscopes
Baxter Anaesthesia Brand of Desflurane
Sevoflurane
Drug: Desflurane
Drug: Sevoflurane
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Health Services Research
Official Title: A Randomized, Double-Blind, Double-Arm Trial Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery Under General Anesthesia With a Laryngeal Mask Airway (LMA)

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Recovery Time [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    Recovery Time after exposure to desflurane or sevoflurane using a standardized wake up


Secondary Outcome Measures:
  • Difference in Time to Orientation [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    Difference in time to orientation as measured by SOMCT between the desflurane group and the sevoflurane group

  • Time to Extubation [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Time from gas discontinuation to eye extubation after eye opening

  • Severity of Coughing [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Effect of desflurane versus sevoflurane on the incidence and severity of coughing using a standardized coughing scale


Enrollment: 75
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Desflurane
Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
Drug: Desflurane
5.4 to 7.4% desflurane
Other Name: Desflurane
Active Comparator: Sevoflurane
Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
Drug: Sevoflurane
1.4 to 2.5% Sevoflurane
Other Name: Sevoflurane

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female, 50 to 75 years of age.
  2. Subjects with an American Society of Anesthesiologist (ASA) physical status of I to III.
  3. Subjects able to provide written informed consent to participate in the study.
  4. Female subjects who have a negative urine or serum pregnancy test, who have been surgically sterilized, or are postmenopausal.
  5. Subjects scheduled for urological cystoscopic surgery under general anesthesia with LMA intubation.

Exclusion Criteria:

  1. Subjects who are prisoners.
  2. Subjects who have limited decision-making capacity or lack the ability to consent.
  3. Subjects with a history of alcohol or drug abuse within the last year.
  4. Subjects with a history of an allergic reaction, intolerance, or contraindications to any of the study medications.
  5. Females who are pregnant or are breastfeeding.
  6. Subjects with BMI greater than 35.
  7. Subjects with a history of hiatal hernia or gastroesophageal reflux disease (GERD).
  8. Subjects with a history of pharyngeal pathology.
  9. Subjects who have participated in or are currently participating in a clinical trial of an investigational drug within 30 days prior to surgery.
  10. Subjects with a fixed decreased pulmonary compliance, such as patients with pulmonary fibrosis.
  11. Subjects with multiple or massive injuries, acute abdominal and/or thoracic injuries.
  12. Subjects with any condition associated with delayed gastric emptying.
  13. Subjects who are profoundly unconscious and who may not resist LMA insertion or have a contraindication for the use of LMA intubation.
  14. Subjects with any condition that in the opinion of the investigator would render the subject ineligible for participation in the study, such as unstable or severe cardiovascular, pulmonary, renal, hepatic, metabolic, or endocrine disease or neuromuscular disorder.
  15. Subjects with a history of malignant hyperthermia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219881

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Baxter Healthcare Corporation
Investigators
Principal Investigator: Joseph Werner, MD Ohio State University
  More Information

No publications provided

Responsible Party: Joseph Werner,MD, Assistant Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT01219881     History of Changes
Other Study ID Numbers: 2010H0174
Study First Received: September 27, 2010
Results First Received: October 30, 2012
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
desflurane
sevoflurane

Additional relevant MeSH terms:
Desflurane
Isoflurane
Sevoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on April 17, 2014